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Celgene Corporation

Associate Specialist, TD Operations Job

Celgene Corporation - San Francisco, CA

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

Summary/Scope

This is an entry level position in the Translational Development Operations (TDOps) department at Celgene.

Under direct supervision in a fast-moving team-based environment, the Associate Specialist will gain

exposure to and develop competency to provide routine biospecimen management and clinical trial support

for oncology and inflammation/immunology programs. The ideal candidate is a demonstrated quick learner

and team-player who is detail-oriented; able to multi-task, supporting several projects simultaneously; has

basic understanding of the broader context and impact of the support that he/she provides; and actively seeks

guidance from peers and managers to learn how to identify and resolve problems.

RESPONSIBILITIES WILL INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING:

The Associate Specialist will participate in activities that support TD and clinical teams in the implementation

and maintenance of a biospecimen management system for clinical studies in some of the following areas under

direct supervision:

1. TD Operations: Develop ability to support assigned clinical protocols and follow good clinical

practices (GCP), standard operating procedures (SOPs) and working procedures (WPs). Perform

assigned tasks that pertain to clinical trial and biomarker operations support.

2. Biospecimen management: Learn how to utilize software tools to track biospecimens, identify

discrepancies, verify and document consent and ensure compliant utilization of biospecimens by

following written procedures. Assist with following up and resolving discrepancies.

3. Clinical study teams: Using basic skills learned in TDOps, execute on assigned tasks on the planning

and designing of clinical biospecimen logistics. Create and update biospecimen laboratory manuals in

collaboration with peers. Will attend study team meetings.

4. CROs and Vendors: Perform assigned tasks as directed by his/her manager on the planning and

designing of clinical biospecimen logistics with preferred vendors and in the manufacture of sample collection kits.

QUALIFICATIONS

Bachelors Degree in a life sciences or healthcare related field with 2+ years related

professional experience in an academic clinical research setting,

clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment

OR

Masters Degree in a life sciences or healthcare related field and 1+ years related

professional experience in an academic clinical research setting,

clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment

Skills/Knowledge Required:

Familiarity with each of the following areas:

Clinical Trials: Familiar with FDA regulatory requirements and GCP and clinical trials.

Scientific/Laboratory Skills: Familiar with laboratory techniques used in the life sciences, principles in

clinical research and clinical procedures involving blood/biopsy collection, handling and processing.

Drug Development: Familiar with the basic drug development process.

Basic computer skills in Microsoft Office.

Experience with databases and intermediate-level Excel a plus.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

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REQ ID: 17000050

PRIMARY LOCATION: United States-California-San Francisco

JOB: Research and Early Development

ORGANIZATION: Celgene Corporation

SCHEDULE: Regular

SHIFT: Standard

EMPLOYEE STATUS: Director

JOB TYPE: Full-time

JOB LEVEL: Day Job

TRAVEL: No

JOB POSTING: 2017-01-10 00:00:00.0

13 days 2 hours ago

Celgene Corporation

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Associate Specialist, TD Operations Job Celgene Corporation - San Francisco, CA, United States

   

Location: San Francisco, CA

Company Profile:
Celgene is a multinational biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our mission as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions. There are numerous clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocyte leukemia (CLL), non-Hodgkin's lymphoma (NHL), glioblastoma, and ovarian, pancreatic and prostate cancer.